Artificial intelligence (AI) and machine learning (ML) seem to be involved in everything, including medical devices and software as a medical device (SaMD). So, regulatory ramifications are possible with such technology and innovation. In this episode, Allison Komiyama and Michelle Rubin-Onur of Acknowledge Regulatory Strategies discuss regulatory guidance documents related to SaMD created by the International Medical Device Regulators Forum (IMDRF) and U.S. Food and Drug Administration (FDA). Some of the highlights of the show include: ● IMDRF’s definition of SaMD is software intended to be used or performed for at least one medical purpose without being part of a hardware medical device. ● SaMD field follows four guidance documents that provide key definitions, risk categorization, quality management systems (QMS), and clinical evaluation. ● Manufacturers are encouraged to provide feedback regarding performance, input, and intended use changes and submissions via FDA’s discussion paper. ● When categorizing SaMD, consider the significance of information provided and state of healthcare situation or condition. ● SaMD must undergo a three-step process: Valid clinical association, analytical validation, and clinical evaluation. ● The benefit of using a QMS to understand and mitigate risks helps FDA understand SaMD. ● To Do List: Complete FDA’s call to action; attend Reg AF Conference; and go to Greenlight Guru’s True Quality Roadshow.